Claritine

Šalis: Armėnija

kalba: anglų

Šaltinis: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Veiklioji medžiaga:

loratadine

Prieinama:

Schering-Plough Labo N.V.

INN (Tarptautinis Pavadinimas):

loratadine

Dozė:

1mg/ml

Vaisto forma:

syrup

Recepto tipas:

OTC

Prekės savybės

Page 1 of 6
Summary of Product Characteristics
Claritine
®
syrup
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Claritine 1 mg/ml syrup
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of syrup contains 1 g of loratadine.
For a full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Syrup
4.
CLINICAL PARTICULARS
_4.1 _
_THERAPEUTIC INDICATIONS _
Claritine syrup is indicated for the symptomatic treatment of allergic
rhinitis and
chronic idiopathic urticaria in adults and children over the age of 2
years.
_4.2 _
_POSOLOGY AND METHOD OF ADMINISTRATION _
Posology
Adults and children over 12 years of age: 10 ml (=10 mg) of the syrup
once daily.
_Pediatric population _
Children 2 to 12 years of age are dosed by weight:
_-_
Body weight of more than 30 kg: 10 ml (=10 mg) of the syrup once
daily.
_-_
Body weight of 30 kg or less: 5 ml (=5 mg) of the syrup once daily.
The safety and efficacy of Claritine syrup in children under 2 years
of age have
not been established. No data are available.
_Patients with liver impairment _
Patients with severe liver impairment should be administered a lower
initial dose
because have reduced clearance of loratadine. An initial dose of 10 mg
every
other day is recommended for adults and children weighing more than 30
kg and
for children weighing 30 kg or less 5 ml (5 mg) every other day is
recommended.
_Patients with renal impairment_
No dosage adjustments are required in elderly patients or in patients
with renal
impairment.
_Elderly patients _
No dosage adjustments are required in elderly patients.
Method of administration
For oral administration. The syrup may be taken without regard to
mealtimes.
_4.3 _
_CONTRAINDICATIONS _
Claritine syrup is contraindicated in patients who are hypersensitive
to the active
substance or to any of the excipients in section 6.1.
Page 2 of 6
Summary of Product Characteristics
Claritine
®
syrup
_4.4 _
_SPECIAL WARNINGS AND PRECAUTIONS FOR USE _
Claritine
should
be
administered
with
caution
in
patients
with
severe
liver
impa